drugset / Trial / NCT01922921
Vaccine Therapy With or Without Polysaccharide-K in Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy
Phase 1/2
Completed
31 enrolled
University of Washington
National Cancer Institute (NCI) · collabNational Center for Complementary and Integrative Health (NCCIH) · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This randomized phase I/II trial studies the side effects of vaccine therapy with or without polysaccharide-K and to see how well it works in treating patients with stage IV human epidermal growth factor receptor 2 (HER2) positive breast cancer who are receiving HER2-targeted monoclonal antibody therapy. Vaccines made from HER2 intracellular domain (ICD) peptide may help the body build an effective immune response to kill tumor cells that express HER2. Polysaccharide-K may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy works better when given with or without polysaccharide-K in treating breast cancer.
Timeline
- Start
- 2014-02-05
- Primary completion
- 2019-10-31
- Completion
- 2021-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HER-2/neu Intracellular Domain Protein | Vaccine | — | Intravenous |
| Subject | Krestin | Unknown | — | Oral |
| Background | Pertuzumab | Monoclonal antibody | — | — |
| Background | Trastuzumab | Monoclonal antibody | — | — |